AMPLATZER PICCOLO OCCLUDER

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Important Safety Information

Indications and Usage

The Amplatzer Piccolo™ Occluder is a percutaneous, transcatheter occlusion device intended for the nonsurgical closure of a patent ductus arteriosus (PDA).

Contraindications

Weight < 700 grams at time of the procedure; Age < 3 days at time of procedure; Coarctation of the aorta; Left pulmonary artery stenosis; Cardiac output that is dependent on right to left shunt through the PDA due to pulmonary hypertension; Intracardiac thrombus that may interfere with the implant procedure; Active infection requiring treatment at the time of implant; Patients with a PDA length smaller than 3 mm; Patients with a PDA diameter that is greater than 4 mm at the narrowest portion

Potential Adverse Events

Potential adverse events that may occur during or after a procedure using this device may include, but are not limited to: Air embolus, Allergic reaction, Anemia, Anesthesia reactions, Apnea, Arrhythmia, Bleeding, Cardiac perforation, Cardiac tamponade, Chest pain, Device embolization, Device erosion, Death, Endocarditis, Fever, Headache/migraine, Hemolysis, Hematoma, Hypertension, Hypotension, Infection, Myocardial infarction, Palpitations, Partial obstruction of aorta, Partial obstruction of pulmonary artery, Pericardial effusion, Pericarditis, Peripheral embolism, Pleural effusion, Pulmonary embolism, Re-intervention for device removal, Respiratory distress, Stroke, Thrombus, Transient ischemic attack, Valvular regurgitation, Vascular access site injury, Vascular occlusion, Vessel perforation

CAUTION: This product is intended for use by or under the direction of a physician. Prior to use, reference the

Instructions for Use provided inside the product carton (when available) or at eifu.abbottvascular.com or at

medical.abbott/manuals for more detailed information on Indications, Contraindications, Warnings, Precautions and

Adverse Events.

Rx Only

Important Safety Information

Indications and Usage

The Amplatzer™ Amulet™ Left Atrial Appendage Occluder is a percutaneous transcatheter device intended to reduce the risk of thrombus embolization from the left atrial appendage

(LAA) in patients who have nonvalvular atrial fibrillation and who are at increased risk for stroke and systemic embolism based on CHADS2 or CHA2DS2-VASc scores, are suitable

for short term anticoagulation therapy, and have appropriate rationale to seek a non-pharmacologic alternative to oral anticoagulation, taking into consideration the safety and

effectiveness of the device.

Contraindications

The Amplatzer™ Amulet™ Left Atrial Appendage (LAA) Occluder is contraindicated for patients:

• with the presence of intracardiac thrombus,

• with active endocarditis or other infections producing bacteremia.

• where placement of the device would interfere with any intracardiac or intravascular structures.

Potential Adverse Events

Potential adverse events associated with the device or implant procedure include, but are not limited to, the following:

• Air embolism

• Airway trauma

• Allergic reaction

• Anemia

• Anesthesia reaction (nausea, vasovagal reaction, confusion/altered mental status or other)

• Arrhythmia

• Atrial septal defect

• Bleeding

• Cardiac arrest

• Cardiac tamponade

• Chest pain/discomfort

• Congestive heart failure

• Death

• Device embolization

• Device erosion

• Device malfunction

• Device malposition

• Device migration

• Device-related thrombus

• Fever

• Hematuria

• Hypertension/hypotension

• Infection

• Multi-organ failure

• Myocardial infarction

• Perforation

• Pericardial effusion

• Pleural effusion

• Renal failure/dysfunction

• Respiratory failure

• Seizure

• Significant residual flow

• Stroke

• Thrombocytopenia

• Thromboembolism: peripheral and pulmonary

• Thrombus formation

• Transient ischemic attack

• Valvular regurgitation/insufficiency

• Vascular access site injury (hematoma, pseudoaneurysm, arteriovenous fistula, groin pain or other)

• Vessel trauma/injury